12 Pain Relievers Recalled in U.S. and Canada After Being “Inadvertently Released”

If you’ve ever dreaded a dental procedure, that dab of numbing gel before an injection can feel like a small mercy. Topical benzocaine gel is a staple for many dental practices, routinely applied to ease the subsequent sting of a needle. Unfortunately, a manufacturing misstep at a New Jersey facility has put several familiar dental brands on the FDA’s recall list.

Keystone Industries, based in Gibbstown, NJ, is the manufacturer behind the recall. During a routine inspection of a mixing vessel, the company’s Quality Unit discovered scratches on the sides and bottom of the vessel and rejected the bulk product. The FDA is reporting that the product was inadvertently released and shipped to customers anyway. On December 13, 2024, the FDA assigned a Class II recall level to the affected lot, meaning that while exposure to the product may cause temporary or medically reversible adverse health consequences, the probability of serious harm is remote. It’s said dental practices were notified of the issue via email.

While the recall is more than a year old and primarily affects dental practices, it sheds light on the rigorous quality standards put upon products administered in the clinical setting, and fosters education on what can go wrong in production. The recalled product was distributed nationwide, as well as in Canada, the Dominican Republic, El Salvador, Honduras, and Qatar.

All 12 recalled products share the same lot number and expiration date:

• Lot: BNZ-001646
• Expiration Date: 11/26/2026

The affected brands are:

• Gelato (Keystone Industries) — Benzocaine 20% Topical Anesthetic Gel, 1 oz.
• M&S Dental Supply Co LLC — Topical Anesthetic Gel, Benzocaine 20%, 1 oz.
• Primo (Primo Dental Products) — Topical Anesthetic Gel, Benzocaine 20%, 1 oz.
• Dental City — Topical Anesthetic Gel, Benzocaine 20%, 1 oz.
• Patterson Dental — Patterson Topical Anesthetic Gel, Benzocaine, 1 oz.
• Health-Tec — Topical Anesthetic Gel, Benzocaine 20%, 1 fl. oz.
• Burkhart (Burkhart Dental Supply) — Topical Anesthetic Gel, Benzocaine 20%, 1 fl. oz.
• Pearson Quality (Pearson Dental Supply) — Topical Anesthetic Gel, 20% Benzocaine, 1 oz.
• Safco SensiCaine Ultra (Safco Dental Supply Co.) — Topical Anesthetic Gel, 20% Benzocaine, Cherry, 1 oz.
• Quala Dental Products — Topical Anesthetic Gel, 20% Benzocaine, 1 oz.
• Ipana (Maxill Inc.) — 20% Benzocaine Topical Gel, 28g
• Henry Schein Benzo-Jel — Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz.

If you work in a dental practice, check the lot number against BNZ-001646 and contact your supplier for guidance on returning or disposing of the affected product.

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